vcr to use new software

New Australian software promises big savings in clinical trials

Nick Evans
Thursday, December 06, 2007

NEW data collection software could save biotech companies up to 60% of clinical trial costs and time, according to the software's developer, Melbourne-based Evado. The new clinical research software aims to replace paper Case Report Forms (CRFs) with an integrated trial reporting system and database.



Photo by Jef Bettens courtesy of Stockxchange

The software, also called Evado (from the Latin "to report", according to the company), has been developed over the last three years as a replacement for existing data collection and reporting systems.

Evado chief executive Jennie Anderson told BTN that the software had the potential to significantly reduce error rates and costs in running clinical trials.

"The software is collecting all of the data required to run a clinical trial," she said.

"The reason we're saving on error rates is that, by using a tablet computer and inputting the data directly into the system, there's no retyping or taking notes from pieces of paper and scribbles.

"And at the moment the other systems that are on the market take quite a lot of work to customise for a trial. Evado is a system that you can customise yourself quickly – in fact, in a matter of days you can be ready to run your trial."

Australia-based heart device company Ventracor will be the first cab off the rank to use the software in a commercial setting. The company plans to use the new software to gather data next year in Australia in a non-regulatory study of patients already implanted with its VentrAssist left ventricular assist device (LVAD).

"The trial manager would set up the trial, taking documentation that's already been developed and cutting and pasting it from a Word document into Evado, and then they would give it to a research nurse, who would go off and do their observations," Anderson said.

The software also allows trial managers to track a patient's appointments and movements, and to upload the patient's medical records into the system.

"This is particularly exciting for device manufacturers," said Anderson.

"Telemetry records, X-rays, reports, path reports, even photos can be uploaded into Evado and all held online."

While the software is yet to see clinical use, the company said that the software application is the result of three and a half years of investment and collaboration with Australian universities, industry bodies and clinical research organisations.

The software will shortly be examined by respected compliance consultants SeerPharma for FDA Part 11 compliance, and Anderson said that the company expects to pass the audit with flying colours.

"We're confident that we're compliant already," she said.

"We've developed software and worked in pharma for many, many years, so we're pretty sure we're right. But we have a Phase 1 starting in January and we have another three we're negotiating so we needed to make sure that we're totally compliant."